Trial Outcomes & Findings for European Active Surveillance Study of Women Taking Hormone Replacement Therapy (HRT) (NCT NCT00214903)
NCT ID: NCT00214903
Last Updated: 2014-12-01
Results Overview
Venous thromboembolism (VTE) linked to the use of continuous combined HRT containing both drospirenone (DRSP) and estradiol (E2) or to other oral continuous combined HRT preparations.
Recruitment status
COMPLETED
Target enrollment
30597 participants
Primary outcome timeframe
within 8.5 years
Results posted on
2014-12-01
Participant Flow
Overall, 31,321 patients were recruited for the EURAS HRT study. 724 patients were excluded due to protocol violations (e.g., patient agreed to participate but never started to use the new HRT preparation or continued to use a previously prescribed preparation).
Participant milestones
| Measure |
DRSP/E2
Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
|
ooccHRT
Users of other oral continuous combined HRT preparations containing other progestogens
|
ooHRT
Users of oral but not continuous combined HRT preparations
|
Non-oral HRT
Users of non-oral HRT preparations
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10043
|
13384
|
4113
|
3057
|
|
Overall Study
COMPLETED
|
10043
|
13384
|
4113
|
3057
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
European Active Surveillance Study of Women Taking Hormone Replacement Therapy (HRT)
Baseline characteristics by cohort
| Measure |
DRSP/E2
n=10043 Participants
Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
|
ooccHRT
n=13384 Participants
Users of other oral continuous combined HRT preparations containing other progestogens
|
ooHRT
n=4113 Participants
Users of oral but not continuous combined HRT preparations
|
Non-oral HRT
n=3057 Participants
Users of non-oral HRT preparations
|
Total
n=30597 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
52.9 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
56.2 years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
54.0 years
STANDARD_DEVIATION 7.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10043 Participants
n=5 Participants
|
13384 Participants
n=7 Participants
|
4113 Participants
n=5 Participants
|
3057 Participants
n=4 Participants
|
30597 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Europe
|
10043 participants
n=5 Participants
|
13384 participants
n=7 Participants
|
4113 participants
n=5 Participants
|
3057 participants
n=4 Participants
|
30597 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: within 8.5 yearsPopulation: The number of participants refers to the ITT study population. During the course of the study, women could for example stop hormonal treatment at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.
Venous thromboembolism (VTE) linked to the use of continuous combined HRT containing both drospirenone (DRSP) and estradiol (E2) or to other oral continuous combined HRT preparations.
Outcome measures
| Measure |
DRSP/E2
n=13 Women-years
Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
|
ooccHRT
n=31 Women-years
Users of other oral continuous combined HRT preparations containing other progestogens
|
ooHRT
n=9 Women-years
Users of oral but not continuous combined HRT preparations
|
Non-oral HRT
n=7 Women-years
Users of non-oral HRT preparations
|
|---|---|---|---|---|
|
Venous Thromboembolism (e.g., Deep Venous Thrombosis and Pulmonary Embolism)
|
24 participants
|
74 participants
|
21 participants
|
12 participants
|
PRIMARY outcome
Timeframe: within 8.5 yearsPopulation: The number of participants refers to the ITT study population. During the course of the study, women could for example stop hormonal treatment at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.
Arterial thromboembolism (ATE) linked to the use of continuous combined HRT containing both drospirenone (DRSP) and estradiol (E2) or to other oral continuous combined HRT preparations.
Outcome measures
| Measure |
DRSP/E2
n=13 Women-years
Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
|
ooccHRT
n=31 Women-years
Users of other oral continuous combined HRT preparations containing other progestogens
|
ooHRT
n=9 Women-years
Users of oral but not continuous combined HRT preparations
|
Non-oral HRT
n=7 Women-years
Users of non-oral HRT preparations
|
|---|---|---|---|---|
|
Arterial Thromboembolism (e.g., Acute Myocardial Infarction and Stroke)
|
15 participants
|
95 participants
|
33 participants
|
23 participants
|
Adverse Events
DRSP/E2
Serious events: 707 serious events
Other events: 0 other events
Deaths: 0 deaths
ooccHRT
Serious events: 1998 serious events
Other events: 0 other events
Deaths: 0 deaths
ooHRT
Serious events: 576 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-oral HRT
Serious events: 508 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DRSP/E2
n=10043 participants at risk
Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
|
ooccHRT
n=13384 participants at risk
Users of other oral continuous combined HRT preparations containing other progestogens
|
ooHRT
n=4113 participants at risk
Users of oral but not continuous combined HRT preparations
|
Non-oral HRT
n=3057 participants at risk
Users of non-oral HRT preparations
|
|---|---|---|---|---|
|
Infections and infestations
Infectious diseases
|
0.12%
12/10043 • Number of events 12 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.21%
28/13384 • Number of events 28 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.19%
8/4113 • Number of events 8 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.29%
9/3057 • Number of events 9 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms, malignant and benign
|
0.91%
91/10043 • Number of events 91 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
1.9%
248/13384 • Number of events 248 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
1.5%
62/4113 • Number of events 62 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
1.9%
58/3057 • Number of events 58 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
|
Blood and lymphatic system disorders
Diseases of the blood and bloodforming organs
|
0.01%
1/10043 • Number of events 1 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.05%
7/13384 • Number of events 7 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.05%
2/4113 • Number of events 2 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.03%
1/3057 • Number of events 1 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
|
Endocrine disorders
Endocrine diseases
|
0.11%
11/10043 • Number of events 11 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.27%
36/13384 • Number of events 36 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.19%
8/4113 • Number of events 8 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.26%
8/3057 • Number of events 8 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
|
Psychiatric disorders
Psychiatric and neurological disorders
|
0.50%
50/10043 • Number of events 50 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.84%
112/13384 • Number of events 112 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.80%
33/4113 • Number of events 33 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
1.0%
32/3057 • Number of events 32 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
|
Eye disorders
Eye
|
0.13%
13/10043 • Number of events 13 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.24%
32/13384 • Number of events 32 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.29%
12/4113 • Number of events 12 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.33%
10/3057 • Number of events 10 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
|
Ear and labyrinth disorders
Ear
|
0.14%
14/10043 • Number of events 14 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.24%
32/13384 • Number of events 32 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.22%
9/4113 • Number of events 9 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.23%
7/3057 • Number of events 7 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
|
Cardiac disorders
Cardiovascular system
|
1.3%
135/10043 • Number of events 135 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
4.0%
542/13384 • Number of events 542 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
3.8%
155/4113 • Number of events 155 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
4.3%
130/3057 • Number of events 130 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory system
|
0.33%
33/10043 • Number of events 33 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.58%
78/13384 • Number of events 78 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.66%
27/4113 • Number of events 27 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.72%
22/3057 • Number of events 22 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
|
Gastrointestinal disorders
Digestive system
|
0.90%
90/10043 • Number of events 90 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
1.8%
237/13384 • Number of events 237 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
1.7%
69/4113 • Number of events 69 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
2.2%
68/3057 • Number of events 68 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin
|
0.07%
7/10043 • Number of events 7 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.18%
24/13384 • Number of events 24 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.12%
5/4113 • Number of events 5 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.16%
5/3057 • Number of events 5 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
|
Musculoskeletal and connective tissue disorders
Muscoskeletal system & connective tissue
|
1.2%
117/10043 • Number of events 117 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
2.1%
285/13384 • Number of events 285 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
2.1%
85/4113 • Number of events 85 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
2.3%
70/3057 • Number of events 70 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
|
Reproductive system and breast disorders
Genitourinary system
|
0.40%
40/10043 • Number of events 40 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.83%
111/13384 • Number of events 111 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.71%
29/4113 • Number of events 29 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
0.79%
24/3057 • Number of events 24 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
|
Injury, poisoning and procedural complications
Injury, poisoning, accidents, etc.
|
0.93%
93/10043 • Number of events 93 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
1.7%
226/13384 • Number of events 226 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
1.8%
72/4113 • Number of events 72 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
2.1%
64/3057 • Number of events 64 • Information on adverse events was collected over a time period of 8.5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
|
Other adverse events
Adverse event data not reported
Additional Information
Juergen Dinger, MD, PhD
Center for Epidemiology and Health Research, Germany
Phone: +49 (0) 30 945 101 20
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place